Pembrolizumab for Recurrent Brain Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen byThomas Kaley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to test if the study drug called pembrolizumab could control the growth or shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by half, or prevent it from growing for at least 6 months. Pembrolizumab is an antibody that targets the immune system and activates it to stop cancer growth and/or kill cancer cells.

Eligibility Criteria

Adults with recurrent malignant glioma and a hypermutator phenotype, who've had prior treatments including radiation and chemotherapy. They must have stable vital functions, no severe allergies to pembrolizumab components, no active infections or autoimmune diseases requiring recent treatment, not be pregnant or breastfeeding, agree to contraception use during the study period, and cannot have received certain other cancer drugs before.

Inclusion Criteria

Tumor recurrence after previous treatment, which must have included at least radiation therapy and one cytotoxic chemotherapy. There is no limit on number of previous recurrences or lines of treatment.

Be ≥ 18 years of age on day of signing informed consent.

Be willing and able to provide written informed consent/assent for the trial.

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Exclusion Criteria

Hypersensitivity to pembrolizumab or any of its excipients.

Has a diagnosis of immunodeficiency, including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (AIDS)

Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

+13 more

Participant Groups

The trial is testing pembrolizumab's effectiveness on brain tumors that recur after standard treatments. It aims to see if this drug can shrink tumors by at least half or prevent growth for six months. Pembrolizumab works by activating the immune system against cancer cells.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab (MK-3475)Experimental Treatment1 Intervention

Pembrolizumab 200 mg will be administered as an approximately 30 minute (-5/+10 mins) IV infusion every 3 weeks. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. Patients will be followed with DCE perfusion MRI done at baseline and every 9 weeks (+/- 7 days). Patients will be allowed to stay on treatment in spite of increase in tumor size, provided the patient has no, or manageable, new neurologic symptoms, and at the discretion of treating physician. In that situation, tumor resection should be encouraged for the distinction between tumor progression and immunologic reactions. Patients undergoing surgical resection will have tissue collected for collateral studies. All collected tissue will be stored in the Pathology Core Tissue bank at MSK.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: